Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe)

Saint Vincent's Hospital, Korea450 enrolled

Overview

This study investigates the impact and safety of wireless monitoring on the prognosis of heart failure patients with implanted pacemakers and defibrillators. It aims to examine the frequency of unplanned early hospital visits and the early diagnosis/intervention of disease exacerbation based on the presence or absence of wireless monitoring. Additionally, the study analyzes the influence of wireless monitoring on the patient's disease progression as well as satisfaction of the study participants.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

450

Conditions

Congestive Heart Failure Defibrillators Cardiac Resynchronization Therapy

Interventions

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * consented heart failure patients (LVEF\<=40%) with Biotronik wireless monitoring capable ICD/CRTs aged \>20 years * patients who are new to remote monitoring Exclusion Criteria: * For patients with a life expectancy of less than 6 months. If patient do not understand the contents of wireless monitoring or it is difficult to fill out the consent form due to cognitive decline. If wireless monitoring is performed with a patient enrolled in another clinical trial which remote monitoring may affect the previous enrolled study.

Outcomes

Primary Outcomes

Unplanned early visits for cardiac causes1 (Patient)

i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits

Time frame: 6 months

Unplanned early visits for cardiac causes2 (Patient)

i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits

Time frame: 12months

Unplanned early visits for cardiac causes3 (Patient)

i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits

Time frame: 18months

Unplanned early visits for cardiac causes4 (Patient)

i. Unplanned hospitalization/admission due to patient's condition changes -\> Patients' needs-driven early visits

Time frame: 24months

Unplanned early visits for cardiac causes1 (Clinic)

ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits

Time frame: 6months

Unplanned early visits for cardiac causes2 (Clinic)

ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits

Time frame: 12months

Unplanned early visits for cardiac causes3 (Clinic)

ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits

Time frame: 18months

Unplanned early visits for cardiac causes4 (Clinic)

ii. Hospitalization/Admission due to alerts on the implanted cardiac device following wireless monitoring -\> Clinician-driven early visits

Time frame: 24months

Secondary Outcomes

Acute myocardial infarction (heart attack) or cerebrovascular events (stroke)

ACS, CVA

Time frame: 6,12,18,24 months

Thromboembolic events (such as pulmonary embolism)

Systemic thromboembolic events

Time frame: 6,12,18,24 months

Worsening of heart failure leading to hospitalization

HF related admission

Time frame: 6,12,18,24 months

Cardiac-related deaths

Cardiac cause deaths

Time frame: 6,12,18,24 months

Overall mortality

overall deaths

Time frame: 6,12,18,24 months

Verifying Remote Monitoring Effect on Net Cardiovascular Outcome; RemoteVerify (RêVe)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes